The present study analyzes the effects of using a portable single limb exoskeleton (MAKv1) in patients with total knee artrhoplasty (TKA). Safety, usability and clinical effects of an early intervention program with the device with an early implementation are studied.
The present study will analyze the safety, usability and clinical effects of using the MAKv1 exoskeleton in TKA patients. The intervention will consist of 1 hour sessions with the MAKv1 device, thrice per week during 1 month. Safety measurements (serious adverse events, vitals, and auto-perceived pain) will be collected at each session with the device, along with the repetitions performed at each exercise assisted with the device. After the first week is completed, measurements regarding clinical effect will be collected. Also, at the end of the month were the participants receive the sessions with the device, clinical effects will be measured again, along with a questionnaire to collect the users' perception of the device (QUEST 2.0).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
6
1 hour sessions with the MAKv1 exoskeleton, thrice per week during 1 month
Hozpital Universitario La Zarzuela
Madrid, Spain
Serious Adverse Events
event that causes death, life-threat, hospitalization, disability, congenital anomaly, or that requires intervention to prevent permanent impairment or damage
Time frame: Through study completion, an average of 2 months
Auto-perceived Pain
Presence of pain collected with VAS scale (0 to 10)
Time frame: Through completion of the use of the device, during 1 month
Heart Rate
Differences in heart rate beofre and after the use of the device (measured in beats/min)
Time frame: Through completion of the use of the device, during 1 month
Blood pressure
Differences in blood pressure before and after the use of the device (measured in mmHg)
Time frame: Through completion of the use of the device, during 1 month
Oxygen Saturation
Differences in oxygen satruation before and after the use of the device (measured in %SpO2)
Time frame: Through completion of the use of the device, during 1 month
Body Termperature
Differences in body temperature before and after the use of the device (measured in celsius)
Time frame: Through completion of the use of the device, during 1 month
Repetitions per exercise
The number of repetitions per exercise assissted by the MAKv1 device was recorded (mesaured in number of repetitions)
Time frame: Through completion of the use of the device, during 1 month
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QUEST 2.0 scale
QUEST 2.0 scale is a usability scale which rates the perception of the user about the device.
Time frame: At the first month of the participation in the trial
Range of Motion at the knee
Range of motion of the knee, measured in degrees (º).
Time frame: Mesaured at the first week, at the first month and at the second month (follow-up) from participation
Muscle strength at the knee
Muscle strength of knee muscles, measured by the modified Medical Research Council scale (mMRC).
Time frame: Mesaured at the first week, at the first month and at the second month (follow-up) from participation
Knee circumference
Circumference of the knee, measured with a metric tape placed at the upper border of the patella (measured in cm)
Time frame: Mesaured at the first week, at the first month and at the second month (follow-up) from participation
Quadriceps circumference
Circumference of the quadriceps, measured with a metric tape placed at 10 cm from the upper border of the patella (measured in cm)
Time frame: Mesaured at the first week, at the first month and at the second month (follow-up) from participation
6MWT
6MWT consists of a test were the subject is asked to walk for 6 minutes and the distance covered is collected (measured in meters)
Time frame: Mesaured at the first month and at the second month (follow-up) from participation
TUG
The Timed Up and Go test consists of a test were the subject is asked to stand up from a chair, cover 3 meters in a straight line, and then go back to sit in the same chair. Time to complete the task is recorded (measured in seconds)
Time frame: Mesaured at the first month and at the second month (follow-up) from participation
FAC
The functional Ambulation Categories scale measures the patient's ability according to the assistance needed to deambulate. A score is given from 0 to 5.
Time frame: Mesaured at the first month and at the second month (follow-up) from participation